Minimally invasive removal device with breakaway sheath

ABSTRACT

A tissue removal device is disclosed which includes an elongate shaft having a distal end and a proximal end, wherein the elongate shaft defines a longitudinal axis, a bag support defining an opening, the bag support being collapsible and expandable to open and close the opening, a bag operatively attached to the bag support, the bag having an open first end operatively secured to the bag support and a closed end, the first end being connected to the support so that when the bag support is in the collapsed position the bag opening is substantially closed, the bag having folds including at least one transverse fold. The tissue removal device may further include a tube for receiving the shaft, bag support and bag.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 60/368,191 filed on Mar. 27, 2002, theentire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to devices used for facilitating theremoval of tissue portions during surgical procedures and, moreparticularly, to devices for removing tissue portions during minimallyinvasive surgical procedures. The present disclosure further relates tomethods of collapsing the devices disclosed herein in order to reducethe cross-sectional profile thereof.

2. Background of Related Art

As a result of technological improvements in surgical instruments,surgical procedures using minimally invasive techniques can be performedcausing less trauma to the patient. It is desirable to use smallerincisions so that a trocar or a cannula inserted into the incision isdesirably smaller. Minimally invasive surgical procedures, however, havetheir limitations as the use of smaller diameter trocars requireincreasingly innovative and novel solutions for many traditionalinstrument applications such as tissue removal instruments. Tissueremoval instruments have tissue removal bags carried on deformable orinflatable frames which also define the opening of the bag. Theinflatable frame instruments have openings that require an additionalsystem for pressurization of the frame and/or bag which may also be aseparately inflated member. Inflatable tissue removal instruments arevulnerable to accidental perforations and/or deflation, and aredependent upon the rigidity of the inflatable structure to support andcontain the tissue as it is loaded into the bag and withdrawn throughthe trocar. It is desirable to decrease the cross-sectional area of theinstrument for use with reduced diameter trocar systems.

A continuing need exists for an improved tissue removal system having areduced cross-sectional diameter for passage through reduced diametercannulas of trocar systems.

SUMMARY

According to one aspect of the present disclosure, a tissue removaldevice includes an elongate shaft having a distal end and a proximalend, wherein the elongate shaft defines a longitudinal axis, a bagsupport defining an opening, the bag support being collapsible andexpandable to open and close the opening, a bag operatively attached tothe bag support, the bag having an open first end operatively secured tothe bag support and a closed end, the first end being connected to thesupport so that when the bag support is in the collapsed position thebag opening is substantially closed. The bag has folds including atleast one transverse fold. It is contemplated that the tissue removaldevice further includes a tube for receiving the shaft, bag support andbag.

It is envisioned that the folds include folds approximately parallelwith the longitudinal axis. It is further envisioned that a sheath isdisposed about the bag assembly. Preferably, the sheath includes aweakness for breaking away from the bag. The sheath can be fabricatedfrom a flexible heat shrinking polymer. It is contemplated that thesheath is in the form of a mesh, a net and/or a lattice.

The tissue removal device further includes an actuation systemoperatively connected to the sheath in order to facilitate removal ofthe sheath from the bag assembly. It is envisioned that the actuationsystem includes a tear line formed in the sheath to facilitate tearingof the sheath. It is further envisioned that the actuation systemincludes a cord operatively connected to the tear line for facilitatingthe tearing of the sheath along the tear line. It is contemplated thatthe cord is connected to a control portion at the proximal end of theshaft.

It is envisioned that the actuation system includes an expandable memberpositioned within the bag assembly. Expansion of the expandable memberis preferably initiated remotely from the bag.

It is further envisioned that the bag has a proximal edge and a distaledge and includes a slot formed in the vicinity of the bag support nearthe proximal edge to enable the diameter of the bag to be adjusted. Inaddition, the bag includes a control line for drawing the slot closed.

The bag can have any shape, including at least one of a conical and atrapezoidal shape. It is further contemplated that the tissue removaldevice includes a control portion operatively coupled to the proximalend of the shaft.

According to another aspect of the present disclosure, a method ofcollapsing a bag of a tissue removal device is disclosed. The methodincludes the steps of providing a minimally invasive tissue removaldevice including a shaft having a distal end and a proximal end anddefining a longitudinal axis, a bag support, and a bag attached to thebag support, the bag having an upper end operatively coupled to the bagsupport and a lower end. The method further includes the step of foldingthe bag transversely with respect to the longitudinal axis. It isenvisioned that the bag is folded onto itself such that the proximaledge crosses the distal edge.

The method further includes the step of at least one of folding the bagso that the folds are approximately parallel to the longitudinal axis.It is envisioned that the bag support has a collapsed position and anexpanded position and further includes collapsing the upper end of thebag using the support. It is further envisioned that the bag is foldedonto its self such that the proximal edge of the bag is substantiallyparallel with the longitudinal axis and/or such that the proximalterminal edge of the bag is substantially aligned with the longitudinalaxis. It is contemplated that the bag is folded so that a portion of thebag is disposed distally of a distal end of the support.

The method further includes the step of placing the folded bag and bagstructure into a sheath. It is envisioned that the sheath includes aweakness and further includes the step of tearing the sheath at theweakness so as to release the bag.

According to a further aspect of the present disclosure, there isprovided a minimally invasive tissue removal device for passage througha cannula, the device including an elongate shaft having a distal endportion and a proximal end portion, the elongate shaft defining alongitudinal axis, and a bag assembly operatively coupled to the distalend portion of the shaft. The bag assembly includes a bag supportstructure having a first position and a second position, and a baghaving an upper end and a lower end, the upper end having an openposition and a closed position and being operatively secured to the bagsupport such that when the bag support is in the first position, theupper end of the bag is substantially open and when the bag support isin the second position, the upper end of the bag is substantiallyclosed, the bag being folded over onto itself so as to form a transversefold.

The tissue removal device further includes a removable sheath disposedabout the bag assembly when in the bag is in the folded condition. It isenvisioned that the bag has a proximal edge and a distal edge andwherein the bag is folded such that the proximal edge is substantiallyaligned with the longitudinal axis.

According to yet another aspect of the present disclosure, there isprovided a minimally invasive tissue removal device for passage througha trocar, the device including an elongate shaft having a distal endportion and a proximal end portion, the elongate shaft defining alongitudinal axis, a bag support at the distal end of the shaft having afirst position and a second position, the bag defining a plane when inthe first position, and a bag having an open end and a closed endopposite the open end, the bag extending along a bag axis which isperpendicular to the longitudinal axis, the bag having an open positionand a closed position, wherein the bag is folded over onto itself suchthat the bag axis is oriented substantially parallel to the longitudinalaxis of the shaft.

It is envisioned that the bag is folded over onto itself, into acylinder adjacent the bag support.

The presently disclosed endoscopic tissue removal device with breakawaysheath, together with attendant advantages, will be best understood byreference to the following detailed description in conjunction with thefigures below.

BRIEF DESCRIPTION OF THE DRAWINGS

By way of example only, preferred embodiments of the present disclosurewill be described herein with reference to the accompanying drawings, inwhich:

FIG. 1 is a cross-sectional view of a tissue removal device with abreakaway sheath in a folded position, in accordance with an embodimentof the present disclosure;

FIG. 2 is a top perspective view of the tissue removal device inaccordance with the embodiment of FIG. 1 in an unfolded position;

FIG. 3 is a side elevational view of the tissue removal device of FIG.1, in a method in accordance with a further embodiment;

FIG. 4 is a side elevational view of the tissue removal device of FIG.3, at a later stage in the method;

FIG. 5 is a side elevational view of a tissue removal device inaccordance with a further embodiment of the present disclosure;

FIG. 6 is a side elevational view of the tissue removal device in amethod in accordance with a further embodiment;

FIG. 7 is a side elevational view of the tissue removal device of-FIG. 6at a later stage in the method;

FIG. 8 is a side elevational view of a tissue removal device inaccordance with another embodiment of the present disclosure; and

FIG. 9 is a side view of a tissue removal device in accordance with theembodiment of FIG. 8 in a folded position.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed endoscopic tissueremoval device will now be described in detail with reference to thedrawing figures wherein like reference numerals identify similar oridentical elements. In the drawings and in the description whichfollows, the term “proximal”, as is traditional will refer to the end ofthe device which is closest to the operator, while the term “distal”will refer to the end of the device which is furthest from the operator.

Referring initially to FIGS. 1-4, one preferred embodiment of a tissueremoval device in accordance with the present disclosure, is showngenerally as 10. Device 10 includes a bag assembly 15, a shaft 30, acontrol system 60 and desirably includes a breakaway sheath 50. Shaft 30defines a longitudinal axis “A”. Bag assembly 15 includes a bag supportstructure or bag support 20 and a bag 40 operatively attached to bagsupport 20.

As seen in FIGS. 2-4, bag support 20 has a distal end portion 22 and aproximal end portion 24. Bag support 20 is deformable and is preferablybiased to an open ring shape. The bag support 20 may comprise anyopenable structure. Bag support 20 may comprise one or more flexibleresilient strips of metal or any other flexible and/or resilientmaterials. Bag support 20 is positioned within a plane A-B defined byaxis “A” and a perpendicular axis “B”. An axis “C” intersects and isperpendicular to axes “A and B”. Bag support 20 is biased to the openposition and is compressible to an elongate configuration wherein thedimension of the ring along minor axis “C” can approach zero, the sidesof bag support 20 are close or in direct contact with one another. Thespecific geometric shape and size of bag support 20 or bag assembly 15is dependent, however, upon the specific application of device 10. Thus,bag support 20 when in the open position can define any shape, such as atwo dimensional geometric opening in the form of an ellipse, a triangle,or an oval, as well as three dimensional openings such as a scoop, forexample.

Pouch or bag 40 is connected to bag support 20 and has a wall 45defining a truncated conical shape. The bag may be connected to the bagsupport by a variety of known means such as the upper end of the bagbeing configured to receive the bag support. The bag 40 includes aflexible film or sheet and may be formed from a substantiallytransparent polymeric material. Polyurethane, latex or any otherbiocompatible material may be used. The bag may have any dimensionssuitable for entrapping and/or removing tissue. A first end 42 of bag 40defines opening 25 and a second end 44 provides a secured or closed endhaving sufficient strength to retain the tissue portions during thewithdrawal of bag assembly 15 through reduced diameter trocars. Bagassembly 15 is desirably suitably configured for use in positioning,isolating, retaining and removing tissue portions during minimallyinvasive surgery.

Device 10 has a first position wherein bag assembly 15 is open such thatbag 40 is unfolded and bag support 20 is uncompressed and defines anopening 25 for receiving tissue portions. In a second position, bagassembly 15 closed so that support 20 is compressed and bag 40 istightly folded, rolled, and/or compressed. The use of the terms orphrase: folding of bag assembly 15, is intended to encompass at leastthe terms such as those identified above that are employed in thegeneral process of folding bag 40 and may include collapsing the bagsupport 20. Folded bag assembly 15 becomes a sheathed bag assembly 51 inthe second position when packaged in breakaway sheath 50. Sheathed bagassembly 51 has a reduced cross-sectional area perpendicular to thelongitudinal axis or diameter for passing through a reduced diametertrocar. Reduced diameter trocars include trocars having inside diametersas small as 12 millimeters, and smaller. It is also envisioned that thepresent disclosure can attain additional reductions in the outsidediameters of sheathed bag assembly 51. Preferably, when bag 40 is in thefirst position, bag 40 generally extends in the direction of axis “C”.

Shaft or pusher 30 has a distal end portion 32 and a proximal endportion 34. Bag assembly 15 is operatively connected with distal endportion 32, such as, by connecting bag support 20 to distal end portion32 of shaft 30. The shaft 30 is desirably formed from a polymericmaterial, but may be formed from any medical grade material. The shaftis slidably received in a tube, as discussed in U.S. Pat. Nos. 5,647,372and 5,465,731, the disclosures of which are entirely incorporated byreference herein. Control portion 60 (symbolically shown) is connectedto proximal end portion 34 for positioning, manipulating and orientingbag support 20 and bag 40 during surgery. Initially, bag assembly 15 isdisposed within the tube and bag 40 is disposed on bag support 20 andcontained in a sheath 50. Shaft 30 is used to position sheathed bagassembly 51 through the reduced diameter trocar and manipulate bagassembly 15 to the first or open position during minimally invasivesurgery. The structure of shaft 30, operational deployment of bagassembly 15 and associated structure are described in commonly ownedU.S. Pat. No. 5,647,372 entitled “Specimen Retrieval Pouch and Method ofUse” and U.S. Pat. No. 5,465,731 entitled “Specimen Retrieval Pouch andMethod of Use,” both of which are incorporated entirely herein byreference. When shaft 30 is advanced through the tube using controlportion 60, the control portion 60 is manipulated so that bag support 20exits the tube. Shaft 30 can have a distal end 32 portion configured tobend or have a hinged connection, for example, which is manipulatablefrom control portion 60 and facilitates orientation of bag 30 after bagassembly 15 has been introduced into the body for receiving tissueportions and any other specimens therein.

Breakaway sheath 50 is configured and adapted to package and retain bagassembly 15 in the second closed position having a reduced dimensionalong the “C” axis. Preferably, breakaway sheath 50 is configured tobreakaway or break apart from bag assembly 15. Breakaway sheath 50preferably includes an easily manipulated release mechanism 55, incontrol portion 60, such that bag assembly 15, including bag 40 and bagsupport 20, can be easily released from sheath 50 by control portion 60.Once sheath 50 is broken away, the bias of bag support 20 and/or bag 40causes bag assembly 15 to expand to the first position.

In one preferred embodiment, breakaway sheath 50 includes a flexiblelayer 52, which may include a medical grade plastic, such as forexample, a single layer of film, or a single or a multilayer laminate.Layer 52 includes a weakness or perforations. Layer 52 has suitablestructural integrity for retaining bag 40 and bag support 20 in thefolded and/or compressed position against any bias inherent in bagassembly 15 toward the second position. Layer 52 can have a uniformthickness, be continuous or discontinuous, provide a hermetic seal, orinclude reinforced portions in a geometric pattern, for example. Layer52 could comprise a sheet, mesh, net, lattice or a combination thereof.

Layer 52 is wrapped around the folded bag 40 so that the folded bag 40is disposed on bag support 20. Layer 52 is preferably configured as ashrink wrapped envelope, tube, or other layer shrunk and/or compressedaround bag assembly 15 when folded in the second closed position. Layer52 preferably closely conforms to and/or is tightly positioned aroundbag assembly 15. Sheath 50 can be fabricated from a suitable range ofmaterials such that sheathed bag assembly 51 can be a flexible or rigidstructure. Thus, it is envisioned that sheathed bag assembly 51 can besufficiently flexible so as to be flexed into an arcuate shape fromcontrol portion 60.

In another alternative embodiment, breakaway sheath 50 can be a rigid orsemi-rigid housing with or without perforations. This configuration canbe employed to mechanically compress and secure bag assembly 15 in afixed position. The housing can also be readily adaptable to vacuumpacking. In operation, the housing could be easily opened using aremotely operated release mechanism 55 operated from control portion 60to disconnect a pin or lever mechanism, for example. The housing can bewithdrawn separately through the reduced diameter trocar after releasingbag assembly 15.

Alternatively, breakaway sheath 50 may be connected to bag assembly 15such that when sheathed bag assembly 51 is released, sheath 50 remainsat least partially connected to bag assembly 15. In this configuration,sheath 50 could be a series of bands or an extended flap connected tobag assembly 1S, for example, such that bag assembly 15 can be securedin the second closed position using the integral bag/sheath combinationand could be held in the second closed position by an adjustablemechanical fastening device as well as by being shrink wrapped.Alternatively, sheath 50 can be connected to bag 40 by a cord or aribbon (not shown). The cord would allow sheath 50 to be withdrawn with,but sequentially after, bag assembly 15, with tissue portions positionedtherein, when sheath 50 is withdrawn through the reduced diametertrocar.

Breakaway sheath 50 may be fabricated from any suitable medical gradeplastic or composite type material having the requisite strength andresistance to stretching. Preferably, the material is heat shrinkable.Alternate embodiments having rigid or semi-rigid enclosures as well asintegral bag 40/sheath 50 systems may be fabricated from one or moresuitable medical grade plastics, composites, or metals.

Release mechanism 55 is activated from control portion 60 by a surgeon.Release mechanism 55 preferably includes the weakness, or perforation,which may comprise an easily openable tear line 59 in layer 52 and anactuation system 56. Tear line 59 can be formed by one or more scorelines, perforation lines, or edges that are continuous, but can bediscontinuous. Actuation system 56 has components such as a suture,wire, pull tab, or cord 57 configured for connecting control portion 60to tear line 59 and for facilitating the tearing of tear line 59 and therelease of sheath 50. For example, a first end of cord 57 is connectedto a distal end of sheath 50 and a second end of cord 57 is disposed atcontrol portion 60 so that sheath 50 can be released by the drawing ofone or more sutures 57 in a proximal direction to rupture sheath 50along tear line 59 and release bag assembly 15. Any other mechanism forreleasing sheath 50 may be used.

Actuation system 56 could also be at least partially positioned as aconnecting mechanism for mating edges of sheath 50. For example, cord 57positioned on opposing edges of sheath 50 could also be a connectingmechanism linking portions of sheath 50 together in the second closedposition. Cord 57 acting as the connecting mechanism could be releasedby a cutting or severing device configured to be pulled proximallyagainst and severing cord 57 thereby releasing sheathed bag assembly 51.In the alternative, release mechanism 55 could be an integral part oflayer 52, such as an elongated pull tab or cord 57, connected to abreakaway mechanical seam such as a zipper or similar mechanical snap orpressure seal configured for opening upon separation or drawing of thetab through the seam.

A further alternative remote actuation system 56 could include, forexample, an expandable portion 58 strategically positioned within bagassembly 15 that could be expanded from control portion 60 to rupturetear line 59 of sheath 50. Expandable portion 58 could be a mechanicaldevice such as a biasing member. Expandable portion 58 may comprise anexpandable bladder in communication with an external source of fluid viacontrol portion 60.

Breakaway sheath 50 can also be configured for an incremental releasethat allows the gradual expansion of sheathed bag assembly 51 from thesecond closed position to the first open position. For example, releasemechanism 55 can include multiple sutures 57 connected with one or moretear lines 59 configured to accommodate a gradual and controlledexpansion of bag assembly 15.

Referring now to FIGS. 3 and 4, a method of folding bag assembly 15 inaccordance with an embodiment is depicted. Embodiments of the inventionare particularly advantageous for a reduced diameter device forintroduction during minimally invasive surgical procedures. Bag assembly15 is positioned from the first open or unfolded position (as seen inFIG. 3) to the second closed or folded position (as seen in FIG. 1) bycompressing bag support 20 such that it forms a narrow shape withopposed bends at the proximal end portion 24 and distal end portion 22.The sides of bag support 20 can be in direct contact with or in closeproximity to one another. The compressing of bag support 20 alsocompresses bag 40 into a flattened shape having a proximal folded edge46 and a distal folded edge 48 such that opposing portions of wall 45are in close to or in direct contact with one another. Bag 40 alsoextends away from bag support 20 to a bottom or second end 44. Bottomend 44 extends in a direction approximately parallel with axis “A”.

Bottom or second end 44 of bag 40 is bent or folded over on itself suchthat proximal folded edge 46 is approximately aligned and in appositionwith bag support 20 and bottom end 44 is disposed so that bottom end 44extends in a direction parallel with axis “C”, as best seen in FIG. 4.This folding step also forms a transverse fold 47 running at an anglerelative to longitudinal axis “A”. In certain embodiments, fold 47 ispreferably approximately 45 degrees relative to longitudinal axis “A”.Transverse fold 47 extends from edge 46 to edge 48. Preferably,transverse fold 47 begins at the junction of the proximal folded edge 46with proximal end portion 24 and extends across bag 40 to distal foldededge 48. Bag 40 is then folded or rolled upward to be disposed parallelto longitudinal axis “A”. Bag 40 may be folded along fold lines 49, forexample, or the bag may be rolled, without creating any fold lines. Thisforms the final folded or second position of bag assembly 15 which isprepared for packaging with breakaway sheath 50, as described above. Thefolding of bag 40 in this manner has been found to produce a low profilefolded bag, such that smaller diameter tubes can be used.

This folding or rolling process advantageously extends bag 40 alonglongitudinal axis “A” prior to the final folding step such that thefolding of the material of bag 40 is extended over a greater distancealong longitudinal axis “A”. This enables bag 40 to be more tightlyfolded and/or rolled into a smaller diameter for packaging and passingthrough reduced diameter trocars. In certain embodiments, the aboveprocess is capable of folding and sheathing bag assembly 15 into aconfiguration having an outside diameter sized for use with a trocarwith an internal diameter of approximately 12 millimeters, or smaller.

It is readily envisioned that further reductions in diameter can be madeto bag assembly 15. For example, the steps of the folding or rollingprocess can be augmented by aspirating bag 40 sufficiently or foldingbag 40 in a vacuum to avoid entrapping air in bag 40 during the foldingprocess. Furthermore, bag 40 may be folded over on itself more than oncebefore bag 40 is folded or rolled upwardly toward bag support 20.

It is also envisioned that the shrink wrap process of sheath 50 canfurther compress or reduce the diameter of bag assembly 15. The shrinkwrap process can also be configured to proceed sequentially along thelongitudinal axis “A”, any other suitable directional orientation, orcombination of directions of bag assembly 15, for example, toadvantageously force air from folded bag 40 to further reduce the volumeof bag 40 before sheathing. In an alternative embodiment, bag 40 isvacuum packed or folded in a vacuum and shrink wrapped/sealed usingflexible plastic layer 52.

The bag may have a wide variety of shapes. Referring now to FIGS. 5-7,reductions in the diameter of a folded bag assembly 15 can be achievedin another embodiment including a bag 140 having a conical shape. Bag140 includes a wall 145 having a first end 142 and a second end 144.First end 142 defines an opening (not shown) while second end 144defines a tip that is a closed end. End 144 points downwardly along axis“C”.

A method of packaging or folding bag 140 in a configuration having a lowprofile, reduced diameter, or small dimension along axis “C”, is alsodescribed herein. Bag 140 is positioned from the first open or unfoldedposition (as seen in FIG. 5) to the second closed or folded position (asseen in FIG. 7) by compressing bag support 20 such that it forms anarrow shape with opposed proximally and distally positioned bendsforming two arcuate sides at distal end 22 and proximal end 24,positioning the sides in contact or in close proximity to one another.The compressing of bag support 20 also compresses bag 140 into a flattriangular shape having a proximal folded edge 146 at the proximal endof bag 140 and a distal folded edge 148 at the distal end of the bag 140such that opposing portions of wall 145 are close or in direct contact.Second end 144 of bag 140 extends away from bag support 20.

Bottom or second end 144 of bag 140 is repositioned or folded on top ofitself such that proximal folded edge 146 is approximately aligned withor approximately parallel to bag support 20 and so that bottom end 44 isdirected along axis “A”. Depending upon the dimensions of the bag, bag140, in the second position, includes second end 144 extending in adistal direction and positioned at least partially distal to edge 148,as shown in FIG. 6. This step also forms a transverse fold 147 startingat end 146 toward end 148, or preferably at the junction of the proximalend 146 with proximal end portion 24 and extending across bag 140 to thedistal folded edge 148. Bag 140 is then folded or rolled upward to bedisposed parallel to longitudinal axis “A” and may be folded along foldlines 149, for example. This forms the final folded reduced diameterposition of bag assembly 15 prior to packaging of bag assembly 15 withbreakaway sheath 50.

As shown in FIGS. 8 and 9, reductions in the diameter of bag assembly 15in the second position can also be achieved by configuring bag 40 to beat least partially separable from bag supports 20, in the vicinity ofbag support 20. Bag 40 is configured with a rim 21 that receives bagsupport 20. In the first position, the first end 42 of the bag is ableto slide along bag support 20 in the at least partially folded position.First end 42 is desirably fixedly connected to bag support 20 at distalend 22 using an adhesive, for example. Bag 40 in this configuration canbe suspended over bag support 20 or at least partially suspended frombag support 20. In this configuration, bag 40 retains its generallyconical shape including second end 44, but has a break or slot 43 in thevicinity of proximal folded edge 46 in the vicinity of proximal endportion 24 configured to enable bag 40 to adjust its diameter and slidearound bag support 20 from proximal end 24 to distal end 22. The slot 43is sized to enable bag 40 to receive bag support 20 when the bag supportis in either the collapsed or expanded positions. Thus, first end 42 ofbag 40 in the vicinity of fold 46 can at least partially separate andslide freely along the sides of bag support 20 for folding into thesecond position. This advantageously accommodates first end 42 beingslid at least partially towards distal end 22 folding bag 40 into a lowprofile configuration. The second end 44 desirably extends distally fromdistal end 22 generally along longitudinal axis “A”, to facilitatefolding into a low profile configuration. Bag 40 can then be rolled orfolded with minimal overlap with bag support 20.

After being passed through the trocar during minimally invasive surgery,first end 42 of bag 40 can be slid along bag support 20 toward proximalend 24, concurrent with or prior to the expansion of bag support 20, bya cord 57. The cord is desirably deployed at control portion 60. In thealternative, bag 40 could be biased to slide toward distal end 22concurrent with the expansion of bag support 20 to the first position.The slot 43 is desirably closed after bag assembly 20 has expanded byfurther drawing control lines 57 proximally such that the sides of slot43 are brought together and slot 43 is closed. In further embodiments,the bag opening 25 may be closed using cord 57 or a separate suture,cord or line.

Although the illustrative embodiments of the present disclosure havebeen described herein, it is to be understood that the disclosure is notlimited to those precise embodiments, and that various other changes andmodifications may be affected therein by one skilled in the art withoutdeparting from the scope or spirit of the disclosure. For example, infurther embodiments, a collapsible or flexible container other than abag may be used. All such changes and modifications are intended to beincluded within the scope of the disclosure.

1. A tissue removal device, comprising: an elongate shaft having adistal end and a proximal end, wherein the elongate shaft defines alongitudinal axis; a bag support defining an opening, the bag supportbeing collapsible and expandable to open and close the opening; a bagoperatively attached to the bag support, the bag having an open firstend operatively secured to the bag support and a closed end, the firstend being connected to the support so that when the bag support is inthe collapsed position the bag opening is substantially closed; and thebag having folds including at least one transverse fold.
 2. The tissueremoval device of claim 1, further comprising a tube for receiving theshaft, bag support and bag.
 3. The tissue removal device of claim 1,wherein the folds include folds approximately parallel with thelongitudinal axis.
 4. The tissue removal device of claim 1, furtherincluding a sheath disposed about the bag assembly.
 5. The tissueremoval device of claim 4, wherein the sheath includes a weakness forbreaking away from the bag.
 6. The tissue removal device of claim 4,wherein the sheath is fabricated from a flexible heat shrinking polymer.7. The tissue removal device of claim 6, wherein the sheath is in theform of at least one of a mesh, net and lattice.
 8. The tissue removaldevice of claim 4, further comprising an actuation system operativelyconnected to the sheath in order to facilitate removal of the sheathfrom the bag assembly.
 9. The tissue removal device of claim 4, whereinthe actuation system includes a tear line formed in the sheath tofacilitate tearing of the sheath.
 10. The tissue removal device of claim9, wherein the actuation system includes a cord operatively connected tothe tear line for facilitating the tearing of the sheath along the tearline.
 11. The tissue removal device of claim 10, wherein the cord isconnected to a control portion at the proximal end of the shaft.
 12. Thetissue removal device of claim 9, wherein the actuation system includesan expandable member positioned within the bag assembly.
 13. The tissueremoval device of claim 12, wherein expansion of the expandable memberis initiated remotely from the bag.
 14. The tissue removal device ofclaim 1, wherein the bag has a proximal edge and a distal edge andincludes a slot formed in the vicinity of the bag support near theproximal edge to enable the diameter of the bag to be adjusted.
 15. Thetissue removal device of claim 14, wherein the bag includes a controlline for drawing the slot closed.
 16. The tissue removal device of claim1, wherein the bag is conical in shape.
 17. The tissue removal device ofclaim 1, wherein the bag is trapezoidal in shape.
 18. The tissue removaldevice of claim 1, further comprising a control portion operativelycoupled to the proximal end of the shaft.
 19. A method of collapsing abag of a tissue removal device, the method comprising the steps of:providing a minimally invasive tissue removal device including a shafthaving a distal end and a proximal end and defining a longitudinal axis;a bag support; and a bag attached to the bag support, the bag having anupper end operatively coupled to the bag support and a lower end, andfolding the bag transversely with respect to the longitudinal axis. 20.The method according to claim 19, wherein the bag is folded onto itselfsuch that the proximal edge crosses the distal edge.
 21. The methodaccording to claim 19, further comprising folding the bag so that thefolds are approximately parallel to the longitudinal axis.
 22. Themethod according to claim 19, wherein the bag support has a collapsedposition and an expanded position and further comprising closing theupper end of the bag using the support.
 23. The method according toclaim 22, wherein the bag is folded onto itself such that the proximalterminal edge of the bag is substantially parallel with the longitudinalaxis.
 24. The method according to claim 19, wherein the bag is foldedonto itself such that the proximal terminal edge of the bag issubstantially aligned with the longitudinal axis.
 25. The methodaccording to claim 20, wherein the bag is folded so that a portion ofthe bag is disposed distally of a distal end of the support.
 26. Themethod according to claim 19, further comprising the step of placing thefolded bag and bag structure into a sheath.
 27. The method according toclaim 26, wherein the sheath includes a weakness and further comprisingtearing the sheath at the weakness so as to release the bag.
 28. Aminimally invasive tissue removal device for passage through a cannula,the device comprising: an elongate shaft having a distal end portion anda proximal end portion, the elongate shaft defining a longitudinal axis;a bag assembly operatively coupled to the distal end portion of theshaft, the bag assembly including: a bag support structure having afirst position and a second position; and a bag having an upper end anda lower end, the upper end having an open position and a closed positionand being operatively secured to the bag support such that when the bagsupport is in the first position, the upper end of the bag issubstantially open and when the bag support is in the second position,the upper end of the bag is substantially closed; the bag being foldedover onto itself so as to form a transverse fold.
 29. The tissue removaldevice according to claim 27, further comprising a removable sheathdisposed about the bag assembly when in the bag is in the foldedcondition.
 30. The tissue removal device according to claim 29, whereinthe bag has a proximal edge and a distal edge and wherein the bag isfolded such that the proximal edge is substantially aligned with thelongitudinal axis.
 31. A minimally invasive tissue removal device forpassage through a trocar, the device comprising: an elongate shafthaving a distal end portion and a proximal end portion, the elongateshaft defining a longitudinal axis; a bag support at the distal end ofthe shaft having a first position and a second position, the bagdefining a plane in the first position; and a bag having an open end anda closed end opposite the open end, the bag extending along a bag axiswhich is perpendicular to the longitudinal axis, the bag having an openposition and a closed position; wherein the bag is folded over ontoitself such that the bag axis is oriented substantially parallel to thelongitudinal axis of the shaft.
 32. The tissue removal device of claim31, wherein the bag is folded into a cylinder adjacent the bag support.